scholarly journals Targeted biologic therapy for asthma

2020 ◽  
Author(s):  
Gareth Hynes ◽  
Ian D Pavord
Keyword(s):  
Biologic Therapy ◽  
Biologic Therapies ◽  
Eosinophilic Asthma ◽  
Heterogeneous Condition ◽  
Superior Efficacy ◽  
Recent Advances ◽  
Effective Treatments

Abstract Background Asthma is a common and potentially serious condition affecting 300 million people worldwide. For many years, we have relied on a one-size-fits-all approach to its management, using corticosteroids and bronchodilators for all symptomatic patients. However, with more recent advances, it has become clear that asthma is a heterogeneous condition with multiple different underlying pathways. Understanding the different subtypes will be a key to giving us the ability to intervene in a targeted way to personalize care for patients with asthma. Sources of data Key published literature, guidelines and trials from clinicaltrials.gov. Areas of agreement The most widely studied of these subtypes is T2 high eosinophilic asthma, for which there are an increasing number of biologic therapies available. T2 high asthma is associated with the cytokines interleukin (IL)-4, IL-5 and IL-13, for each of which biologics have been developed. Areas of controversy It is currently unclear which of the available biologics provides superior efficacy. It is also unclear how to select which biologic for which patient. Growing points Head-to-head trials of the available T2 biologics will be important to determine superiority, and a suggested order for trialling biologics. Going further than this, we would like to see further analyses of available biologics to allow us to predict responders from non-responders in advance of administering therapy. Areas timely for developing research Non-eosinophilic T2 low asthma is an area that is under-researched and for which there are few treatments available. It is likely that there are different subtypes in this category of asthma and unravelling what these are will be crucial to developing effective treatments.

Applying personalized medicine to adult severe asthma

2021 ◽  
Vol 42 (1) ◽  
pp. e8-e16 ◽  
Author(s):  
Angelica Tiotiu
Keyword(s):  
Personalized Medicine ◽  
Severe Asthma ◽  
Negative Impact ◽  
Target Therapy ◽  
Asthma Management ◽  
Future Research ◽  
Biologic Therapies ◽  
Eosinophilic Asthma ◽  
Definition Of ◽  
Structured Approach

Background: Severe asthma is a heterogeneous disease that consists of various phenotypes driven by different pathways. Associated with significant morbidity, an important negative impact on the quality of life of patients, and increased health care costs, severe asthma represents a challenge for the clinician. With the introduction of various antibodies that target type 2 inflammation (T2) pathways, severe asthma therapy is gradually moving to a personalized medicine approach. Objective: The purpose of this review was to emphasize the important role of personalized medicine in adult severe asthma management. Methods: An extensive research was conducted in medical literature data bases by applying terms such as “severe asthma” associated with “structured approach,” “comorbidities,” “biomarkers,” “phenotypes/endotypes,” and “biologic therapies.” Results: The management of severe asthma starts with a structured approach to confirm the diagnosis, assess the adherence to medications and identify confounding factors and comorbidities. The definition of phenotypes or endotypes (phenotypes defined by mechanisms and identified through biomarkers) is an important step toward the use of personalized medicine in asthma. Severe allergic and nonallergic eosinophilic asthma are two defined T2 phenotypes for which there are efficacious targeted biologic therapies currently available. Non-T2 phenotype remains to be characterized, and less efficient target therapy exists. Conclusion: Despite important progress in applying personalized medicine to severe asthma, especially in T2 inflammatory phenotypes, future research is needed to find valid biomarkers predictive for the response to available biologic therapies to develop more effective therapies in non-T2 phenotype.

scholarly journals Biologic and Glucocorticoid Use after Methotrexate Initiation in Patients with Rheumatoid Arthritis

2018 ◽  
Vol 46 (4) ◽  
pp. 343-350 ◽  
Author(s):  
Michael D. George ◽  
Brian C. Sauer ◽  
Chia-Chen Teng ◽  
Grant W. Cannon ◽  
Bryant R. England ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Patient Outcomes ◽  
Biologic Therapy ◽  
Age Groups ◽  
Biologic Therapies ◽  
Factors Associated ◽  
Therapy Initiation ◽  
Patients With Heart Failure ◽  
To Receive ◽  
Improve Disease Control

Objective.Biologic therapies can improve disease control for patients with rheumatoid arthritis (RA) but may be both overused and underused. We aimed to identify predictors of greater use of biologic therapies and to identify factors associated with persistent glucocorticoid use.Methods.Using national US Veteran’s Affairs databases 2005–2016, we identified patients with RA receiving a first-ever prescription of methotrexate (MTX), requiring ≥ 6 months of baseline data. We evaluated predictors of biologic therapy initiation within 2 years of starting MTX and factors associated with baseline and persistent glucocorticoid use at 6–12 months using multivariable models.Results.Among 17,415 patients starting MTX, 3263 patients received biologic therapy within 2 years (20.6% 2-yr incidence). In adjusted analyses, biologic use was substantially lower in older patients [e.g., aHR 0.20 (95% CI 0.16, 0.26) for patients ≥ 80 vs < 50] and patients with more comorbidities [aHR 0.79 (95% CI 0.72, 0.87) for Charlson score ≥ 3 vs < 3]. Patients with heart failure [aHR 0.68 (95% CI 0.54, 0.84)], cancer [aHR 0.78 (95% CI 0.66, 0.92)], or who were nonwhite [aHR 0.79 (95% CI 0.72, 0.87)] were also less likely to receive a biologic. In contrast, baseline and persistent glucocorticoid use was similar across age groups and more common in patients with greater comorbidity.Conclusion.Biologic therapy is initiated less frequently in patients with RA who are older, have more comorbidities, and who are nonwhite. While biologics may be avoided in older and sicker patients because of safety concerns, glucocorticoid use is similar regardless of age and is more frequent in patients with comorbidities, with implications for patient outcomes.

Biologic Therapy Utilization in Patients With Moderate to Severe Psoriasis and Psoriatic Arthritis: An Observational Summary of Biologic Therapy Use in a Clinical Setting

2018 ◽  
Vol 22 (6) ◽  
pp. 567-576 ◽  
Author(s):  
Wayne P. Gulliver ◽  
Shane Randell ◽  
Susanne Gulliver ◽  
Valerie Gregory ◽  
Sean Nagle ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Clinical Research ◽  
Plaque Psoriasis ◽  
Biologic Therapy ◽  
Severe Psoriasis ◽  
Second Line ◽  
Biologic Therapies ◽  
Biologic Treatment ◽  
Treatment Pathways ◽  
Severe Plaque Psoriasis

Plaque psoriasis affects approximately 2% to 3% of the global population, with psoriatic arthritis observed in approximately 20% to 30% of these individuals. Upon advances in research pathophysiology and treatment over the past decade, biologic therapies have been used more to treat moderate to severe psoriasis. In Canada, reimbursement bodies have defined prior authorization criteria to determine patient eligibility for funding of biologic treatments in moderate to severe plaque psoriasis. Generally, patients will have been treated with conventional therapies such as topical steroids, phototherapy, or systemic treatments such as methotrexate and cyclosporine before starting a biologic therapy. In difficult cases or severe flares in otherwise controlled disease, practitioners may augment the regimen with one or more conventional treatments. The objective of this observational report was to identify treatment pathways for psoriasis and psoriatic arthritis patients in Canada by examining initial biologic treatment and subsequent treatment optimization patterns for informed reimbursement discussions and decisions. A retrospective chart review was conducted at Newlab Clinical Research using medical records of patients who received at least 1 of 4 biologic agents approved at that time of the survey in Canada for the treatment of plaque psoriasis (adalimumab, etanercept, infliximab, ustekinumab). The study population consisted of patients who had moderate to severe plaque psoriasis, diagnosed by a dermatologist, for at least 6 months before the study index date and who attended Newlab Clinical Research between 2008 and 2013. All current and previous agents prescribed for the treatment of psoriasis were captured. A total of 248 patients with psoriasis treated with biologics were identified, of whom 27 (10.9%) were also diagnosed with psoriatic arthritis. Prior to initiating treatment with a biologic, most patients (72.1%) were treated with (or contraindicated to) methotrexate/cyclosporine. Treatment was supplemented with topical agents (70.6%) and/or followed by a course of ultraviolet light phototherapy (51.6%). Only 2.4% of patients were treated with a biologic first. Of 248 patients treated with biologics, almost half (47.6%) needed add-on therapy, whereas 16.5% of patients had an increase in dose or dosing interval. Furthermore, 14.1% of patients added a topical agent, 10.5% a topical steroid, or 6.5% a course of phototherapy while continuing biologic therapies. Finally, 30.4% of patients switched to another biologic treatment. Adalimumab was the most common agent used as a second-line agent (37.2%), and patients who started on adalimumab mainly switched to ustekinumab as a second-line agent (73.9%). Infliximab was the agent least often used as second-line therapy.

P004 A PERSPECTIVE ON PORTRAYAL: MEN AND MINORITIES ARE UNDER-REPRESENTED ON BIOLOGIC WEBSITES

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S46-S47
Author(s):  
Vinay Rao ◽  
Scott Baumgartner ◽  
Ali Khan ◽  
Marie Borum
Keyword(s):  
Biologic Therapy ◽  
Minority Group ◽  
White Male ◽  
People Of Color ◽  
Biologic Therapies ◽  
Minority Representation ◽  
Inflammatory Bowel ◽  
Racially Ambiguous ◽  
Facial Images ◽  
Improve Patient

Abstract Introduction Biologics are important options for inflammatory bowel disease (IBD) management. It has been reported that people of color (POC) with IBD are less frequently prescribed biologics compared to whites. Drug manufacturers’ websites are often designed to improve patient awareness and understanding of medical conditions and treatment. There is a paucity of information evaluating racial minorities depicted on pharmaceutical websites focused on biologic therapy. This study evaluated minority representation on websites of common biologic therapies used for IBD. Methods Websites for 4 major biologics were evaluated (Humira, Remicade, Stelara, Entyvio) for minority representation. Stock photos and videos were analyzed. Individuals were categorized based upon perceived ethnicity (person of color [POC], racially ambiguous [RA], white), gender, and role (patient, provider). Individuals were categorized independently by 3 investigators. Repeat images, incomplete facial images, inactive background role in videos, or images in which there was disagreement among all investigators were excluded. Statistical analysis was performed using two-sample t-test with significance set at p&lt;0.05. Results In the 4 websites, there were 102 total subjects (49 photos, 53 videos). There were 89 white, 11 POC, and 2 RA subjects with 33 males (32 white, 1 POC, 0 RA) and 69 females (57 white, 10 POC, 2 RA). There were significantly less POC compared to whites in photos (14.2% vs 81.6%; p=0.0003) and videos (7.0% vs 93.0%; p=0.001). Males were less frequently represented than females in photos (33.3% vs 66.7%; p=0.0096) and videos (32.3% vs 67.7%; p=0.0238). There were no males of color in photos. Humira portrayed 10 POC, Entyvio portrayed 1 POC and none were identified on Remicade and Stelara websites. Humira included 1 white, male provider, and Remicade 1 female POC provider. Stelara and Entyvio included no providers in either photos or videos. There were no images or videos about which all 3 reviewing investigators disagreed. All websites included at least 1 image with which a single investigator disagreed. Only Humira and Vedolizumab included a video with single investigator disagreement. Discussion Biologic therapy has a significant role in IBD treatment and should be considered for all IBD patients who have the appropriate indications. Pharmaceutical websites can have a role in increasing patient understanding and acceptance of therapy. Patients may have increased acceptance of treatment based upon portrayed images. While this study revealed that males and POC were significantly less represented on biologic websites, it may reflect gender and minority group IBD prevalence. However, consideration should be given to increase minority representation on biologic websites to enhance male and POC acceptance of therapeutic options and potentially improve clinical outcomes.

scholarly journals Adherence to corticosteroids and clinical outcomes in mepolizumab therapy for severe asthma

2020 ◽  
Vol 55 (5) ◽  
pp. 1902259 ◽  
Author(s):  
Gráinne d'Ancona ◽  
Joanne Kavanagh ◽  
Cris Roxas ◽  
Linda Green ◽  
Mariana Fernandes ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Biologic Therapy ◽  
Inhaled Corticosteroids ◽  
Final Analysis ◽  
Good Adherence ◽  
Eosinophilic Asthma ◽  
Exacerbation Rate ◽  
Asthmatic Patients ◽  
Severe Eosinophilic Asthma ◽  
Asthma Patients

IntroductionInhaled corticosteroids (ICS) achieve disease control in the majority of asthmatic patients, although adherence to prescribed ICS is often poor. Patients with severe eosinophilic asthma may require treatment with oral corticosteroids (OCS) and/or biologic agents such as mepolizumab. It is unknown if ICS adherence changes on, or alters clinical response to, biologic therapy.MethodsWe examined ICS adherence and clinical outcomes in OCS-dependent severe eosinophilic asthma patients who completed 1 year of mepolizumab therapy. The ICS medicines possession ratio (MPR) was calculated (the number of doses of ICS issued on prescription/expected number) for the year before and the year after biologic initiation. Good adherence was defined as MPR >0.75, intermediate 0.74–0.51 and poor <0.5. We examined outcomes after 12 months of biologic therapy, including OCS reduction and annualised exacerbation rate (AER), stratified by adherence to ICS on mepolizumab.ResultsOut of 109 patients commencing mepolizumab, 91 who had completed 12 months of treatment were included in the final analysis. While receiving mepolizumab, 68% had good ICS adherence, with 16 (18%) having poor ICS adherence. ICS use within the cohort remained similar before (MPR 0.81±0.32) and during mepolizumab treatment (0.82±0.32; p=0.78). Patients with good adherence had greater reductions in OCS dose (median (interquartile range) OCS reduction 100 (74–100)% versus 60 (27–100)%; p=0.031) and exacerbations (AER change −2.1±3.1 versus 0.3±2.5; p=0.011) than those with poor adherence. Good ICS adherence predicted the likelihood of stopping maintenance OCS (adjusted OR 3.19, 95% CI 1.02–9.94; p=0.045).ConclusionICS nonadherence is common in severe eosinophilic asthma patients receiving mepolizumab, and is associated with a lesser reduction in OCS requirements and AER.

Type and Quantity of Pharmacologic Therapy for Crohn's Disease before Eventual Surgical Treatment

2016 ◽  
Vol 82 (10) ◽  
pp. 989-991 ◽  
Author(s):  
Jan P. KamiŃSki ◽  
Emily Miraflor ◽  
Karen Zaghiyan ◽  
Phillip Fleshner
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Biologic Therapy ◽  
Pharmacologic Therapy ◽  
Aminosalicylic Acid ◽  
Biologic Therapies ◽  
Pharmaceutical Treatment ◽  
Prospective Data ◽  
Therapeutic Modalities ◽  
Patient Demographics

Treatment of Crohn's disease (CD) relies on medical therapy with surgery reserved for medically refractory cases. This study measured pharmaceutical therapies that CD patients receive before surgery. Prospective data were collected on 558 patients undergoing surgery for medically refractory CD from November 1999 through June 2014. Patient demographics and preoperative medical therapies were tabulated, including types and number of doses of aminosalicylic acid, corticosteroids, immunomodulators, and biologic therapies. Most patients had been treated with preoperative aminosalicylic acid (72%), steroids (77%), or immunomodulators (69%). Forty-two per cent of patients were treated with a biologic before surgery with a mean number of 20 doses (range, 1–130). In 29 per cent of patients, all therapeutic modalities were used before surgery. Biologic therapy was more common in the last seven years of the study compared with the first eight years (64% vs 35%; P < 0.01). More patients had been treated with all therapeutic modalities before surgery in the second half of the study period (37% vs 19%; P < 0.01). CD patients undergoing surgery have had extensive pharmaceutical treatment. In the current era, more patients have been placed on biologic therapies and more than one third of them failed all available classes of medications before surgical intervention.

scholarly journals O10 Combining clinical and ultrasound assessment to taper biologic therapies in patients with RA in routine clinical practice

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Harikrishnan Pillai ◽  
Nilesh Nolkha ◽  
Augustus Yau ◽  
Susan Matthews ◽  
Alison Hall ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Practice ◽  
Clinical Remission ◽  
Biologic Therapy ◽  
Power Doppler ◽  
Cost Savings ◽  
Routine Clinical Practice ◽  
Biologic Therapies ◽  
Ultrasound Assessment ◽  
Baseline Frequency

Abstract Background There is growing evidence for tapering biologic therapies in patients with rheumatoid arthritis in sustained clinical remission to avoid overtreatment and minimise side-effects. Ultrasound assessment for subclinical synovitis adds to clinical assessment of patients with rheumatoid arthritis suitable for tapering biologic therapies. Our primary objective was to combine clinical and ultrasound assessment to select patients with rheumatoid arthritis for tapering biologic therapies in routine clinical practice. The secondary objectives were to identify predictors for successful tapering and assess the cost savings to the local health economy by optimising the use of high cost drugs. Methods All patients with rheumatoid arthritis on a biologic therapy for 2 years and in sustained clinical remission (DAS28≤2.6) over the previous year were seen in the remission clinic. They had an Ultrasound scan of the small joints of the hands, wrists and other symptomatic joints. Patients with no activity on Power Doppler were advised to lengthen the interval of their biologic therapy gradually and were followed once every 3 months. Patients were not on oral steroids but continued conventional DMARDs. Patients had a dedicated helpline if they had a flare. Results Ninety-three of the 120 patients with rheumatoid arthritis on biologic therapy seen in the biologic remission clinic between January and October 2019 were eligible and all but one agreed to taper. They were 70% female with a mean age of 62.8 years and mean duration of disease 14.6 years. Their mean duration of biologic therapy was 6.3 years; mean baseline DAS28 was 6.3 pre-biologic therapy and 1.7 before tapering. Fifty-seven of the patients were on a TNF inhibitor and 35 were on other biologic therapies. Forty of the ninety-two patients were co-prescribed DMARDs. Screening failure was due to clinical activity in 13 patients, Ultrasound Power Doppler activity in 23 patients, interstitial lung disease in 2 patients and shoulder surgery in one. Only two of the 40 patients who had completed 6 months had a flare and reverted to the baseline frequency. Of the remaining 52 patients, 22 patients had completed 3 months at the tapered dose and 3 patients who were in the initial 3 months had a flare and reverted to the baseline frequency. Initial drug-cost savings at 6 months was approximately £45,000. Conclusion Tapering of biologic therapies in patients with rheumatoid arthritis is feasible in routine clinical practice. Ultrasound is helpful to stratify patients for biologic tapering and has enabled a higher proportion of patients to remain in remission after tapering. Disclosures H. Pillai: None. N. Nolkha: None. A. Yau: None. S. Matthews: None. A. Hall: None. G. Hirsch: None. S. Venkatachalam: None.

scholarly journals Apremilast in the treatment of psoriatic arthritis: a perspective review

2017 ◽  
Vol 9 (2) ◽  
pp. 45-53 ◽  
Author(s):  
Michael Reed ◽  
David Crosbie
Keyword(s):  
Psoriatic Arthritis ◽  
Biologic Therapy ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Efficacy And Safety ◽  
Biologic Therapies ◽  
Phosphodiesterase 4 ◽  
Psoriatic Disease ◽  
New Treatment ◽  
Orally Active

Apremilast is an orally-active small molecule which inhibits phosphodiesterase-4 (PDE4). Clinical trials have demonstrated its efficacy and safety in psoriatic arthritis (PsA) and psoriasis. Established therapeutic options have variable effectiveness across the different domains of psoriatic disease. Whilst biologic therapies have proven to be of significant benefit to many patients, not all patients respond, and others are not eligible or do not tolerate biologic therapy. We review the mechanism of action, pharmacokinetics and clinical trial data with regards to both efficacy and safety for apremilast and consider where this new treatment may be positioned in the treatment of PsA.

scholarly journals 416a – Vedolizumab Shows Superior Efficacy Versus Adalimumab: Results of Varsity—The First Head-To-Head Study of Biologic Therapy for Moderate-To-Severe Ulcerative Colitis

2019 ◽  
Vol 156 (6) ◽  
pp. S-81 ◽  
Author(s):  
Bruce E. Sands ◽  
Laurent Peyrin-Biroulet ◽  
Edward V. Loftus ◽  
Silvio Danese ◽  
Jean Frederic Colombel ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Biologic Therapy ◽  
Severe Ulcerative Colitis ◽  
Superior Efficacy
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